Medical Device Regulatory Updates – November 2023
Extension of EU MDR Transition
The MDR was amended through Regulation (EU) 2023/607, which took effect on March 20, 2023, in accordance with directives from the European Parliament and Council. The primary objective of these amendments is to uphold a robust level of public health protection, encompassing patient safety, and to prevent any disruptions in the availability of medical devices crucial for the seamless operation of healthcare services. These changes do not compromise the existing requirements of quality or safety.
The EU MDR transition periods for devices transitioning to the EU MDR from May 26, 2024, have been extended to:
- May 26, 2026 for class III implantable custom-made devices
- December 31, 2027 for class III and implantable class IIb devices
- December 31, 2028 for non-implantable class IIb and lower risk devices
- December 31, 2028 for class I sterile, or class I devices with measuring function
The manufacturer must provide a self-declaration confirming that the extension conditions are fulfilled, along with the transition period’s end date. This declaration could be based on a harmonised template and should clearly specify the devices and certificates under the extension. Additional evidence could be provided by a ‘confirmation letter’ issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonised template and be issued, in principle, without extra costs. The manufacturer could demonstrate that he has lodged an application for conformity assessment and concluded a written agreement with a notified body also by other means, such as a copy of the relevant documents.
In August 2023, the European Commission published a guidance document featuring a comprehensive flowchart for ‘legacy devices’, and class III custom-made implantable devices. The flowchart can assist the manufacturers in determining whether their medical device falls under the extended transitional period outlined in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), which has been amended by Regulation 2023/607.
UKCA Marking Guidance for Medical Devices
The UKCA (UK Conformity Assessed) marking is the product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland). The UKCA marking applies to most products for which the CE marking could be used. The UK government intends to extend the recognition of the CE marking for placing medical devices on the market in Great Britain, indefinitely, beyond December 2024.
Medical devices are governed by the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period (following the UK’s departure from the EU), gave effect in UK law to the directives listed below:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
This means that the current regulatory pathway for medical devices entering the Great Britain market and UKCA marking requirements are based on the requirements established by the aforementioned EU legislation. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the designation and monitoring of UK conformity assessment bodies. In case of a third-party conformity assessment required for UKCA marking, a UK Approved Body is needed. However, manufacturers of non-sterile and non-measuring Class I devices and general IVDs can self-certify against the UKCA marking.
Based on MHRA acceptance of (EU) 2023/607, MDD/AIMDD certified medical devices may be placed on the GB market as follows (only if requirements set out in (EU) 2023/607 are met):
- Class III and IIb implantable non-WET devices till December 2027
- Class IIb WET, Class IIa, Class Im, and Class Is devices till June 2028
BSI provides more information on UKCA marking along with the UKCA Roadmap on their website.
US FDA 510k Submission Using eSTAR
The electronic Submission Template and Resource (eSTAR) offers comprehensive guidelines for the electronic submission of (510(k)) submissions, a timeline for implementation of these standards, and criteria for waivers and exemptions from statutory requirements. All 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR starting October 1, 2023.
The eSTAR is freely accessible and available for voluntary use by all medical device applicants seeking to submit 510(k)s, De Novo requests, and Pre-Submissions to the Center for Devices and Radiological Health (CDRH), and medical device applicants wishing to submit 510(k)s to the Center for Biologics Evaluation and Research (CBER). The eSTAR is now also available for use with combination products. The eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.
For further information, you can access the US FDA website which also provides the eSTAR template.